The purpose of the present study is comparison of intra-articular injection of hyaluronic acid with corticosteroids in reducing pain in patients with knee osteoarthritis . This study is a randomized clinical trial study . Inclusion criteria :1)Patients with moderate to severe osteoarthritis of the knee 2)The patient agreed to participate in the study ,Exclusion criteria :1)Unstable joint 2)Necrosis 3)Bleeding disorders 4)Joint fracture 5)Injection site infection 6)Joint prosthesis 7)Previous history of tuberculosis 8)Surgery in the past 12 months and inability of follow up patients because of migration or death .In this study ,50 patients who fulfilled inclusion criteria for the study were selected .Demographic information such as age , sex , weight , duration of illness and ... ask them and recorded in a special form. At baseline , patients taught about the purpose of the plan and that their treatment is a research work and intra-articular injection of hyaluronic acid and corticosteroids maybe have relative efficacy of the treatment .Also the possibility of cross effects were noted and written consent shall be taken from them . Patients randomly divided into two groups of 25 . In first group ,40 milligram methylprednisolone and in second one 20 milligram hyaluronic acid is injected into the knee joint . VAS (Visual Analogue Scale ) used to determine the severity of pain .Before injection the severity of pain with the criteria will be determined , and patients one month and three months after the injection will be followed up and severity of pain , their satisfaction and improvement will be evaluated .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015041213828N6
Registration date:2015-05-11, 1394/02/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-05-11, 1394/02/21
Registrant information
Name
Ahmad Mirdamadi
Name of organization / entity
Islamic Azad university ,Najafabad branch
Country
Iran (Islamic Republic of)
Phone
+98 31 1223 8028
Email address
drsamirdamadi@pmd.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2015-06-05, 1394/03/15
Expected recruitment end date
2016-11-05, 1395/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intra-articular injection of Hyaluronic acid with Corticosteroids in reducing pain in patients with knee osteoarthritis
Public title
Effect of Hyaluronic acid in the treatment of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :
1)Patients with moderate to severe osteoarthritis of the knee
2)The patient agreed to participate in the study
Exclusion criteria :
1)Unstable joint
2 )necrosis
3)Bleeding disorders
4)Joint fracture
5)Injection site infection
6)Joint prosthesis
7)Previous history of Tuberculosis
8)Surgery in the past 12 months
9)Inability of follow up patients after injection because of migration or death
Age
From 40 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
School of Medicine ,Isfahan University,Azad Square, Isfahan
City
Isfahan
Postal code
8174673441
Approval date
2015-04-11, 1394/01/22
Ethics committee reference number
494005
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17.0
ICD-10 code description
Primary gonarthrosis , bilateral
Primary outcomes
1
Description
Severity of pain
Timepoint
Before the intervention,one month and three months after intervention
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Satisfaction of treatment
Timepoint
Before the intervention ,one month and three months after intervention
Method of measurement
Standard questionnaire
Intervention groups
1
Description
Amp Hyaluronic acid 20mg ,IA,one dose per week for three consecutive weeks
Category
Treatment - Drugs
2
Description
Amp Methylprednisolone 40mg ,IA, an injection in the baseline and patients may receive another injection during the study period
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthopedic Clinic /Dr. Ali Shariaty Hospital
Full name of responsible person
Dr. Behnam Haghpanah (Orthopedic Surgeon )
Street address
Dr. Ali Shariaty Hospital ,Shariaty Street, Chaharbagh Bala Street, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Orthopedic Clinic /Dr. Ali Shariaty Hospital
Full name of responsible person
Dr. Behnam Haghpanah (Orthopedic Surgeon)
Street address
Dr. Ali Shariaty Hospital,Shariaty Street,Chaharbagh Bala Street,Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Orthopedic Clinic /Dr. Ali Shariaty Hospital
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University ,Najafabad Branch
Full name of responsible person
Dr. Ahmad Mirdamadi
Position
Cardiologist,Fellowship of Echocardiography /Assistant Professor of medical school
Other areas of specialty/work
Street address
Islamic Azad University, Najafabad Branch,University Blvd,Najafabad,Isfahan
City
Isfahan
Postal code
8514143131
Phone
+98 31 4229 1111
Fax
+98 31 4229 1016
Email
drsamirdamadi@yahoo.com
Web page address
www.iaun.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
School of Medicine/Islamic Azad University , Najafabad Branch
Full name of responsible person
Farah Shahin
Position
Medical Student
Other areas of specialty/work
Street address
School of Medicine ,Islamic Azad University ,Najafabad Branch ,University Blvd , Najafabad , Isfahan
City
Isfahan
Postal code
8514143131
Phone
+98 31 4229 1111
Fax
+98 31 4229 1016
Email
farahshahin660@yahoo.com
Web page address
www.iaun.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)